Patient interface with forehead and chin support

ABSTRACT

A patient interface gas delivery mask having a forehead and chin support system including a forehead support, a chin support, and a system for supplying a flow of gas to a patient that incorporates such a mask, forehead support, and chin support. The forehead support includes a supporting arm which is adjustably mounted to the mask shell, thereby allowing the adjustment of the distance between the forehead support bracket and the mask shell in order to adjust for patient&#39;s of different sizes. A forehead support bracket is pivotally connected to the support arm. Likewise the chin support is also adjustably mounted to the mask shell.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a Continuation of and claims priority under 35U.S.C. §120 from U.S. patent application Ser. No. 10/953,642, whichclaims priority under 35 U.S.C. §119(e) from provisional U.S. patentapplication No. 60/508,574 filed Oct. 3, 2003 the contents of each whichare incorporated herein by reference.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention generally relates to a patient interface devicefor use in a pressure support system that supplies a flow of gas to theairway of a patient, and, in particular to a patient interface devicethat includes a forehead and a chin support system and to a pressuresupport system that includes such a patient interface device.

2. Description of the Related Art

There are numerous situations where it is necessary or desirable todeliver a flow of breathing gas non-invasively to the airway of apatient, i.e., without intubating the patient or surgically inserting atracheal tube in their esophagus. For example, it is known to ventilatea patient using a technique known as non-invasive ventilation. It isalso known to deliver continuous positive airway pressure (CPAP) orvariable airway pressure, such as a bi-level pressure that varies withthe patient's respiratory cycle or an auto-titrating pressure thatvaries with the monitored condition of the patient. Typical pressuresupport therapies are provided to treat a medical disorder, such assleep apnea syndrome, in particular, obstructive sleep apnea (OSA), orcongestive heart failure.

Non-invasive ventilation and pressure support therapies involve theplacement of a patient interface device, which is typically a nasal ornasal/oral mask, on the face of a patient to interface the ventilator orpressure support system with the airway of the patient so that a flow ofbreathing gas can be delivered from the pressure/flow generating deviceto the airway of the patient. It is known to maintain such masks on theface of a patient by a headgear having upper and lower straps, eachhaving opposite ends threaded through connecting elements provided onthe opposite sides and top of a mask.

Because such masks are typically worn for an extended period of time, avariety of concerns must be taken into consideration. For example, inproviding CPAP to treat OSA, the patient normally wears the patientinterface device all night long while he or she sleeps. One concern insuch a situation is that the patient interface device is as comfortableas possible, otherwise the patient may avoid wearing the interfacedevice, defeating the purpose of the prescribed pressure supporttherapy. It is also important that the interface device provide a tightenough seal against a patient's face without discomfort. A problemarises in that in order for the mask to maintain a seal without anyundue gas leaks around the periphery of the mask, the mask may becompressed against the patient's face. This is most notable, forexample, in masks having a bubble type cushion. While the bubble cushionitself is comfortable, it does not provide adequate support which maycause gas leaks around the periphery of the mask. The bubble effect isdiminished when the headgear strap force is increased to improvestability.

It is known to provide a patient interface device that includes aforehead support that contacts the patient's forehead to provide asupport mechanism between the mask and the patient's forehead. Gasdelivery masks having forehead cushions, spacers or supports aredescribed, for example, in U.S. Pat. Nos. 4,907,584; 5,243,971;5,517,986; 5,570,689; 6,119,693; and 6,357,441; 6,467,483. The foreheadsupports prevent the mask from exerting too much force on a patient'sface and provides stability to the mask.

Another mask with forehead support is disclosed in InternationalPublication No. WO 00/78384 A1. In this arrangement a forehead supportis adapted to be secured to a respiratory mask. The forehead supportincludes a joining member for securing to the mask and a cushion framepivotally mounted to the joining member.

However, an advantage exists for increased stability of the gas deliverymask support. Another advantage exists for a support which evenlydistributes headgear strapping force by utilizing both forehead and chinsupports. A further advantage exists for increased isolation of the gasdelivery mask support from the mask cushion.

SUMMARY OF THE INVENTION

An exemplary embodiment of the present invention comprises a patientinterface device having a forehead support assembly and a chin supportassembly, both of which are coupled to a mask shell. In a furtherembodiment, including adjustably controlling a position of the foreheadsupport assembly, the chin support assembly, or both relative to themask shell.

An exemplary embodiment of the present invention, the forehead supportassembly includes a forehead support arm operatively coupled to the maskshell and a forehead support bracket mounted on the forehead supportarm, and the chin support assembly includes a chin support armoperatively coupled to the mask shell and a chin support bracket mountedon the chin support arm. This configuration for the patient interfacedevice provides adjustment along an axis or curve which is normal to theplane of the mask shell to adjust for patients of different sizes andshapes. The adjustment assembly allows a patient to adjust the mask insuch a way as to minimize leakage and pressure on certain areas of theface, such as the nose bridge.

Like forehead supports, the chin support of the present inventionprovides relief of pressure and improved stability. Additionally, thechin support of the present invention eliminates the unpleasant pressureon the cheek area common with known strapping arrangements. Also, therelocation of the mounting force below the cushion (unlike currentarrangements with the mounting force situated along the center line ofthe cushion) helps to stabilize the mask. When wearing a nasal mask, thechin support helps eliminate leak in the area above the lips. Inoral-nasal masks, seal capability is improved.

These features and characteristics of the present invention, as well asthe methods of operation and functions of the related elements ofstructure and the combination of parts and economies of manufacture,will become more apparent upon consideration of the followingdescription and the appended claims with reference to the accompanyingdrawings, all of which form a part of this specification, wherein likereference numerals designate corresponding parts in the various figures.It is to be expressly understood, however, that the drawings are for thepurpose of illustration and description only and are not intended as adefinition of the limits of the invention. As used in the specificationand in the claims, the singular form of “a”, “an”, and “the” includeplural referents unless the context clearly dictates otherwise.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of the patient interface device accordingto the principles of the present invention shown (schematically)connected to a gas flow generating system;

FIG. 2 is a side view of the patient interface device of FIG. 1;

FIG. 3 is a front view of the patient interface device of FIG. 1;

FIG. 4 is a back view of the patient interface device of FIG. 1;

FIG. 5 is a perspective view of a second embodiment of a patientinterface device according to the present invention;

FIG. 6 is a side view of the patient interface device of FIG. 5;

FIG. 7 is a perspective view of a third embodiment of a patientinterface device according to the present invention;

FIG. 8 is a perspective view of a fourth embodiment of a patientinterface device according to the present invention;

FIG. 9 is a side of the patient interface device of FIG. 8;

FIG. 10 is a front view of the patient interface device of FIG. 8;

FIG. 11 is a detailed perspective view of the forehead support assemblyof the patient interface device of FIG. 8;

FIG. 12 is a detailed perspective view of the chin support assembly ofthe patient interface device of FIG. 8;

FIG. 13 is an exploded perspective view of a fifth embodiment of apatient interface device according to the present invention;

FIG. 14 is a perspective view of a portion of the patient interfacedevice of FIG. 13;

FIG. 15 is a perspective view of the chin support assembly of thepatient interface device of FIG. 13;

FIG. 16 is an exploded, front perspective view of the chin supportassembly of the patient interface device of FIG. 13;

FIG. 17 is an exploded, rear perspective view of the chin supportassembly of the patient interface device of FIG. 13; and

FIG. 18 is a perspective view of a sixth embodiment of a patientinterface device according to the present invention.

DETAILED DESCRIPTION OF THE PRESENTLY PREFERRED EMBODIMENTS OF THEINVENTION

In describing the presently preferred embodiments of the invention, theterms “horizontal” and “vertical” refer to the orientation of the maskas illustrated in the accompanying drawings. More specifically,“horizontal” refers to a left-right or side-to-side direction, and“vertical” refers to an up-down or top-bottom direction.

FIGS. 1-4 illustrate an exemplary embodiment of a patient interfacedevice according to the principles of the present invention. Thesefigures illustrate a patient interface device 10 that communicates aflow of breathing gas between a patient's airway and a pressuregenerating device 12, such as a ventilator, CPAP device, or variablepressure device, e.g. an auto-titrating device, proportional assistventilation (PAV) device, proportional positive airway pressure (PPAP)device, C-Flex device, Bi-Flex device, or a BiPAP® device manufacturedand distributed by Respironics, Inc. of Pittsburgh, Pa., in which thepressure provided to the patient varies with the patient's respiratorycycle so that a higher pressure is delivered during inspiration thanduring expiration, or other pressure support device. It should be notedthat the term “mask” or “mask assembly” is also used herein to refer tothe patient interface device.

Referring to FIGS. 1-4, patient interface device 10 includes a maskshell 14 or body portion, which is preferably, but not necessarily, agenerally rigid, formed structural shell having an open side thatdefines an annular portion 16 to which a resilient, relatively softcushion or seal member 18 is attached. In the illustrated exemplaryembodiment, mask shell 14 is substantially triangular in shape, havingan upper apex 20 and two lower angles 22. Mask shell 14 includes aninlet opening 24 adapted to receive a gas supply conduit 26, which isalso referred to in the art as a patient circuit. It is to be understoodthat the present invention contemplates that the mask shell can have anyshape suitable to serve as a patient interface. Mask shell 14 ispreferably formed from rigid plastic, such as polycarbonate. Seal member18 is configured to contact a portion of the patient, such as the areaof the face surrounding the nose, so that a portion of the patient, suchas the nose, is received within the cavity defined within the maskshell. Alternatively, patient interface 10 may, instead, comprise anasal/oral mask configured to enclose the nose and mouth of a patient oran oral mask configured to enclose only the mouth of a patient.

Mask shell 14 is essentially supported on the patient's face by aforehead support assembly, generally indicated at 28, and a chin supportassembly, generally indicated at 30. Forehead support assembly 28,which, according to the illustrated exemplary embodiment, is generallyT-shaped, includes a forehead support arm 32 and a forehead supportbracket 36 attached thereto. In the illustrated exemplary embodiment,the forehead support bracket is coupled to an upper end portion 34 offorehead support arm 33. Forehead support arm 32 can be attached toforehead support bracket 36 in a fixed fashion or in an adjustablefashion. The latter configuration is illustrated in FIGS. 1-4, and isdiscussed in greater detail below.

A pair of forehead pads 38 are provided on the patient contacting sideof forehead support bracket 36. Forehead pads 38 form the actual contactpoint of forehead assembly 28 to the patient's forehead. As such, theforehead pads are preferably made from a material that is biocompatibleand comfortable to the touch. In an exemplary embodiment of the presentinvention, the forehead pads are formed from an elastomeric cushioningmaterial, such as silicon.

In the illustrated embodiment, the forehead pads 38 comprise two pads,one mounted on each of the end portions 40 of the forehead supportbracket 36. Also, the forehead pads have a generally semi-cylindricalshape. The present invention contemplates the forehead pads 38 can beany suitable cushioning element and may include a single pad and/ordifferent sizes or variations or formed from alternative materials suchas gel, foam, or silicone. Examples of other forehead pads suitable foruse in the present invention are described in U.S. patent applicationSer. No. 10/884,060 (publication no. US-2005-0011522-A1), the contentsof which are incorporated herein by reference.

Each end portion 40 of the forehead support bracket, preferably includesa connector element 42 (FIG. 3) for securing an upper headgear strap 44.In this preferred embodiment, connector element 42 is a female receivingslot for receiving a male quick release element 46 attached to an upperheadgear strap 44. However, it should be understood that otherconnection mechanisms can be used to attach the headgear to the foreheadsupport bracket, including the ball and socket configuration forsecuring a lower headgear strap to the chin support assembly. The balland socket configuration, and other headgear attachment configurationssuitable for use with the present invention, are disclosed in co-pendingU.S. patent application Ser. No. 10/629,366, the contents of which areincorporated herein by reference.

Forehead support assembly 28 further includes a forehead adjustmentassembly, generally indicated at 48 in FIG. 3, to provide adjustment offorehead support bracket 36 relative to mask shell 14. In the embodimentillustrated in FIGS. 1-4, forehead adjustment assembly providesadjustment of the forehead support assembly along an axis or curve, asindicated by arrow A in FIG. 2, to allow the patient interface to beadjusted to accommodate patients of different sizes, shapes, and comfortdesires. Forehead adjustment assembly 48 allows a patient to adjust themask in such a way as to minimize leakage and pressure on certain areasof the face, such as the nose bridge, as discussed below. The presentinvention contemplates that any one of a wide variety of adjustmentmechanisms can be used to adjust forehead support bracket 36 relative tomask shell 14. Several of these mechanisms are illustrated in thepresent application.

In the embodiment illustrated in FIGS. 1-4, forehead adjustment assembly48 is defined by components that also define forehead support arm 32.That is, forehead support arm 32 includes an arcuate attaching member 52and an arcuate support member 53. An end portion 50 of arcuate supportmember 53 is slidably coupled to an upper end portion 51 of arcuateattaching member 52, so that forehead support bracket 36 is adjustablyconnectable to mask shell 14. Arcuate attaching member 52 is coupled tomask shell 14 and extends from a central portion of the mask shell aboveinlet opening 24 to a position spaced above upper apex angle 20 of themask shell. Arcuate attaching member 52 has a generally tubular crosssection having an exterior guide slot 54 having opposed ratchet-liketeeth 56.

Arcuate support member 53 of support arm 32 also has a generally tubularcross section, is adapted to slide within arcuate attaching member 52,and has a central protrusion 58 corresponding to guide slot 54. Centralprotrusion 58 is located on a flexible member having ratchet teeth (notillustrated) on either side either of the central protrusion. Whencentral protrusion 58 is depressed, the flexible member flexes allowingthe ratchet teeth to disengage from each other so that arcuate supportmember 53 and attaching member 52 can move relative to each other.

The present invention contemplates a different number of opposed teethcould be used, as well as the teeth could be on the bracket portion andthe protrusion could be on the shell portion. In the illustratedembodiment, arcuate support member 53 is integral with mask shell 14. Itis to be further understood, however, that an adjustable coupling can beprovided between these two components. Also, these components need notbe integrally joined.

It can be appreciated from the above description and the accompanyingillustrations, that forehead adjustment assembly 48 of the presentinvention allows forehead support assembly 28, including foreheadsupport arm 32, forehead support bracket 36, and forehead pads 38, tomove relative to mask shell 14 in two general directions simultaneously.First, the entire forehead support assembly 28 moves in a generallyvertical direction, i.e., in a direction parallel to the plane in whichthe mask shell 14 lies, to move forehead pads 38 closer to or away frommask shell 14, as indicated by arrow B in FIG. 4. Second, the entireforehead support 28 moves in a generally horizontal direction, i.e., ina direction generally perpendicular to the plane in which mask shell 14lies, as indicated by arrow C, in FIG. 2.

This simultaneous, two dimensional movement is made possible by thecurvilinear shape of forehead adjustment assembly 48, and, moreparticularly, the curvilinear shape of attaching member 52 and supportmember 53. This allows forehead support assembly 28 to be adjusted forthe optimal, i.e., most comfortable, fit on the patient. Morespecifically, movement of the forehead support relative to the maskshell in this manner has the effect of controlling a distance 55 (SeeFIG. 2) between the patient and mask shell 14 at upper apex 20.Controlling distance 55, in turn, primarily controls the force that thecushion exerts on the surface of the patient at the bridge of the nose.Because the bridge of the nose is a particularly sensitive area for manypatients, allowing adjustment of the mask shell at upper apex 20 viaforehead support assembly 28, allows the patient to have a great degreeof control over the mask comfort and fit.

As noted above, the present invention contemplates providing anadjustable connection between forehead support arm 32 and foreheadsupport bracket 36. This is accomplished in the present embodiment byproviding a pivoting coupling between these two elements. Morespecifically, protruding pivot mounts 60 are provided on opposite sidesof arcuate support member 53. Forehead support bracket 36 includes apair of corresponding openings 62, so that pivot mounts 60 are pivotallyreceivable within the openings 62. This configuration allows foreheadsupport bracket 36 to pivot relative to forehead support arm 32 about anaxis through pivot mounts 60, as indicated by arrow 57 in FIG. 2.

In the illustrated embodiment, this pivoting movement is not lockable,so that the forehead support bracket will naturally seek its idealposition relative to the forehead support arm when the forehead supportassembly is positioned on the patient. It is to be understood, however,that the present invention contemplates providing a locking mechanism sothat the position of the forehead support bracket relative to theforehead support arm can be locked. In addition, the pivoting structureshown in the figures and described above is subject to variations. Forexample, the pivot mounts can be provided on the forehead supportbracket and the opening for the mounts provided on the forehead supportarm.

Chin support assembly 30, according to the illustrated exemplaryembodiment, is generally T-shaped and includes a chin support arm 64 anda chin support bracket 66. In the illustrated embodiment, chin supportbracket 66 is a substantially rigid cup-shaped member that includes anouter surface 68 opposite an inner surface 70. Inner surface 70 ispreferably concave-shaped to receive the chin of the patient. A softpadding piece 72 is preferably attached to the inner surface forincreased comfort and stability.

In the illustrated exemplary embodiment, chin support assembly 30includes a lower headgear connector assembly 74, which includes a pairof first connectors 76 rigidly attached to chin support bracket 66.Lower headgear straps 78 of the headgear assembly are selectivelyconnected to patient interface device 10 by means of second connectors80. In the illustrated embodiment, a pair of second connectors 80, areremovably connectable to end portions of headgear straps 78 and are alsoremovably connectable to first connectors 76 on each side of the chinsupport bracket 66. In the illustrated embodiment, first and secondconnectors 76 and 80 are ball-and-socket connectors corresponding tothose disclosed in U.S. patent application Ser. No. 10/629,366(publication no. US-2004-0025883-A1). It is to be understood, however,that the present invention contemplates using any conventionalconnection assembly for attaching the lower headgear to the chin supportassembly.

Like forehead support assembly 28, chin support assembly 30 alsoincludes a chin adjustment assembly, generally indicated at 82 in FIG.3. More specifically, chin adjustment assembly 82 provides adjustment ofthe chin adjustment assembly along an axis or curve, as indicated byarrow D in FIG. 2, to allow the patient interface to be adjusted toaccommodate patients of different sizes, shapes, and comfort desires.Chin adjustment assembly 82 allows a patient to adjust the mask in sucha way as to minimize leakage and pressure on certain areas of the face,such as the nose bridge, as discussed below. The present inventioncontemplates that any one of a wide variety of adjustment mechanisms canbe used to adjust chin support bracket 36 relative to mask shell 14.Several of these mechanisms are illustrated in the present application.

Chin adjustment assembly 82 illustrated in this embodiment, allows chinsupport bracket 66 to move relative to mask shell 14 in two generaldirections simultaneously. First, chin support bracket 66 moves in agenerally vertical direction, i.e., in a direction parallel to the planein which the mask shell 14 lies, to move chin support bracket 66 closerto or away from mask shell 14, as indicated by arrow E in FIG. 4.Second, chin support bracket 66 moves in a generally horizontaldirection, i.e., in a direction generally perpendicular to the plane inwhich mask shell 14 lies, as indicated by arrow F, in FIG. 2.

In the embodiment illustrated in FIGS. 1-4, chin adjustment assembly 82is defined by components that also define chin support arm 64. That is,chin support arm 64 includes an arcuate attaching member 86 and anarcuate support member 65. An end portion 84 of arcuate support member65 is slidably coupled to an end portion 83 of arcuate attaching member86, so that chin support bracket 66 is adjustably connectable to maskshell 14. Arcuate attaching member 86 is coupled to mask shell 14 andextends from a central portion of the mask shell below inlet opening 24.

Arcuate attaching member 86 and arcuate support member 65 of chinsupport arm 64 are connected to each other using a ratchet-typeconnection like that used in forehead support arm 32. Thus, the detailsof the ratchet-type connection between mask shell 14 and chin supportbracket 66 are omitted for the sake of brevity. In addition, arcuateattaching member 86 and arcuate support member 65 have complimentarytubular shapes to provide a stable, yet adjustable, coupling betweenthese two member.

This simultaneous, two dimensional movement is made possible by thecurvilinear shape of chin adjustment assembly 82, and, moreparticularly, the curvilinear shape of attaching member 86 and supportmember 65. This allows chin support assembly 30 to be adjusted for theoptimal, i.e., most comfortable, fit on the patient. More specifically,movement of the chin support relative to the mask shell in this mannerhas the effect of controlling a distance 81 (See FIG. 2) between thepatient and mask shell 14 at a lower portion thereof. Controllingdistance 81, in turn, primarily controls the force that the cushionexerts on the surface of the patient below the nose.

In the illustrated exemplary embodiment, chin support bracket 66 isadjustably connected to an end portion 67 of arcuate support member 65in chin support arm 54 via a slide-and-rotate arrangement. That is, chinsupport bracket 66 can both slide and rotate with respect to chinsupport arm 64. To achieve this dual functionality, end portion 67 ofthe chin support arm includes protruding pivot axis 88 on opposite sidesthereof. Outer surface 68 of chin support bracket 66 includes a pair ofcorresponding arcuate members 90 having an outer edge 92 and an inneredge 94. Inner edge 94 includes at least one and, in this illustratedembodiment, four grooves 96 in which pivot axis 88 is receivable. Outersurface 68 of chin support bracket 66 further includes protrusions 98opposite grooves 96, and which lay along a preset locus. Pivot axis 88slides along inner edge 94 between grooves 96, so that the chin supportbracket 66 can move independently of the motion of chin support arm 64with respect to mask shell 14.

It can be appreciated that this configuration for the chin supportbracket provides three independent positional adjustments for the chinsupport bracket relative to the mask shell. First, the chin supportbracket moves in a lengthwise direction along attaching member 86, asindicated by arrow D. Second, the chin support bracket moves in asliding direction within inner edge 94 between the grooves, as indicatedby arrows 99 a and 99 b in FIG. 2. Finally, the chin support bracketpivots about axis 88, as indicated by arrow 97.

The present invention contemplates the headgear that can be used withthe patient interface device can be any suitable headgear, i.e., anyconventional headgear used in the patient interface field. For example,a typical headgear assembly comprises a headpiece (not shown) thatoverlies a portion of the patient's crania and with a pair of lowerheadgear straps and a pair of upper headgear straps extending therefromto adjustably connect the headgear to the mask.

Alternative exemplary embodiments of the patient interface device of thepresent invention are illustrated in FIGS. 5-18. In these embodiments,many features are similar to those illustrated in FIGS. 1-4. Thus, thedescription of these embodiments will focus primarily on the features ofthe patient interface device unique to each embodiment. Thesealternative embodiments are provided primarily to show the differentconfigurations that are possible for the mask shell and cushion, theforehead and chin support assemblies, and sub-components thereof. It isto be understood that the present application contemplates mixing andmatching the features of the patient interface device illustrated in allof these embodiments. For example, the chin support assembly of FIG. 7can be used in conjunction with the forehead support assembly of FIG. 1.

Like in the embodiment of FIGS. 1-4, patient interface device 10′ of thesecond embodiment illustrated in FIGS. 5 and 6 includes a foreheadsupport assembly 28′ having forehead adjustment assembly 48′ to provideadjustment of forehead support bracket 36′ relative to mask shell 14. Inthis embodiment, forehead adjustment assembly 48′ includes arcuateattaching member 52′ and arcuate support member 53′, both of whichdefine forehead support arm 32′ and both of which have generallyU-shaped cross sections that are connected to each other using aratchet-type connection. Attaching member 52′ has guide slots 54′ oneach side of its U-shape. Central guide slot 54′ has opposedratchet-like teeth 56′. Support member 53′ is adapted to slide withinarcuate attaching member 52′ and has a central protrusion 58′corresponding to the central guide slot 54′ along with guide protrusions99 corresponding to the other two guide slots 101 (only one of which isshown).

Like the embodiment of FIG. 1-4, central protrusion 58′ is located on aflexible member corresponding having ratchet teeth (not illustrated) oneither side of central protrusion 58′. When central protrusion 58′ ispressed inwardly, the flexible member flexes inwardly allowing theratchet teeth to disengage from each other so that arcuate supportmember 53′ and arcuate attaching member 52′ can move relative to eachother. In this embodiment, forehead bracket 36′ is rigidly coupled toarcuate support member 53′.

Like the chin adjustment assembly of FIGS. 1-4, chin adjustment assembly82′ of FIGS. 5 and 6 includes a chin support assembly 30′ that includesa chin support arm 64′. Chin support arm 64′ includes an arcuateattaching member 86′ and an arcuate support member 65′ connected to eachother using a ratchet-type connection like that used in the foreheadsupport arm. As with the embodiments of FIGS. 1-4, the relativemale-female relationships between the bracket portion and the shellportion of the adjustment assemblies can be reversed.

Unlike the previous embodiment, a lower end portion of chin support arm64′ is generally bifurcated forming two parallel vertical walls 100 eachhaving protrusions 102 on the lower end. An outer surface 68′ of chinsupport bracket 66′ includes a pair of corresponding arcuate members 104forming a pair of arched grooves 106 for receiving the protrusions.Movement of protrusions 102 in grooves 106 causes chin support bracket66′ to move relative to chin support arm 64′ in a sliding manner, asindicated by arrow G in FIG. 6. In this manner, the position of chinsupport bracket 66′ relative to chin support arm 64′ and mask 14′ isallowed to “float” so that the best position for the chin supportbracket is achieved without user intervention. This self-aligningfeature allows the chin support bracket, for example, to remain parallelto the patient's chin at all times, thus enhancing comfort andstability. It should be emphasized that this “floating” or“self-aligning” functionality can also be used for the forehead supportassembly.

A third exemplary embodiment for a patient interface device 110 isillustrated in FIG. 7. Like in the previous embodiments, the foreheadsupport assembly in this embodiment includes a forehead adjustmentassembly 112 having a forehead support bracket 113 and a foreheadsupport arm 114, and the chin support assembly includes a chinadjustment assembly 116 having chin support bracket 117 and a chinsupport arm 118. In this illustrated embodiment, the mask shell includesa collar 120. A seal member or cushion 122 is fixed to collar 120 sothat the seal member does not move relative to the collar. The presentinvention also contemplates coupling the seal to the collar in a movablefashion.

Unlike the previous embodiments, forehead support arm 114 and chinsupport arm 118 single-piece flexible elements attached to oppositesides of collar 120. In the illustrated embodiment, forehead support arm114 and chin support arm 118 are attached to collar 120 with a livinghinge 124, 124′ disposed at the attachment point of each support armwith the collar. This configuration allows the forehead and chin supportarms to flex and bend to allow for greater flexibility in the attachmentof the patient interface device to the user.

In an exemplary embodiment, living hinge 124, 124′ includes a notchedportion 126, 126′ of reduced thickness at the bases of forehead and chinsupport arms 114 and 118. Each notched portion preferably has a diameterthat is oriented generally perpendicular to forehead and chin supportarms 114 and 118. Living hinges 110 allow forehead and chin support arms114 and 118 to flex in a direction perpendicular to the plane in whichthe collar 120 is oriented.

Forehead and chin support arms 114 and 118 further include adjustmentslots 128, 128′, which allow forehead and chin support brackets 113 and117 to slide up and down relative to the forehead and chin support armsfor further adjustment. That is, a selectively actuated latchingmechanism (not shown), such as an engagement pin disposed on a spring,is provided on forehead and chin support brackets 113 and 117. Thislatching mechanism engages one or more of the slots on the support armsfor locking the support brackets in a fixed position on the support arm.It is to be understood, that other techniques for controlling theposition of the support brackets on the support arm, such as a frictionlock, are contemplated by the present invention.

In the illustrated exemplary embodiment, collar 120 and seal 122correspond to the mask assembly described in U.S. Pat. No. 6,412,488,the contents of which are incorporated herein by reference and in U.S.Pat. No. 6,651,663, the contents of which are also incorporated hereinby reference. It is to be understood, however, that the presentinvention contemplates providing other sizes and configurations forcollar 120 and seal 122 is shown as a generally circular structure.

In the illustrated embodiment, forehead adjustment assembly 112 and chinadjustment assembly 116 are substantially identical. It is to beunderstood, however, that the present invention does not require this tobe the case. Forehead adjustment assembly 112 and chin adjustmentassembly 116 can have different configurations, adjustment portions,pads, etc. For example, the present invention contemplates providing achin cup, as described in the previous embodiments, as chin supportbracket 117.

A fourth exemplary embodiment for a patient interface device 150 isillustrated in FIGS. 8-12. Like in the previous embodiments, thisembodiment includes a forehead support assembly 152 having a foreheadsupport bracket 154 and a forehead support arm 156, and a chin supportassembly 160 having chin support bracket 162 and a chin support arm 164.In this illustrated embodiment, the forehead and chin support assembliesare connected to a mask shell 166 that includes a chamber for receivinga portion of user's face, such as the nose, and an opening to which thepatient circuit 26 is attached. A patient contacting cushion (not shown)is attached to an end portion 168 of mask shell 166 in a fixed orremovable fashion.

Forehead support arm 156 includes a forehead adjustment assembly 157that allows for adjustment of the relative position between foreheadsupport bracket 154 and mask shell 166. Similarly, chin support arm 164includes a chin adjustment assembly 165 that allows for adjustment ofthe relative position between chin support bracket 162 and mask shell166. It is to be understood, however, that either or both the foreheadadjustment assembly and chin adjustment assembly can be eliminated fromthis embodiment (or any other embodiment) in favor of providing a fixedposition between the forehead support bracket and mask shell or the chinsupport bracket and mask shell.

This fourth embodiment for the patient interface device is similar tothe first embodiment, except for the attachment of the forehead supportbracket to the forehead support arm and the configuration for chinsupport bracket 162. Thus, the description of this embodiment will focuson these features of patient interface device 150. Again, it is to beunderstood that the unique features of one embodiment for the patientinterface device can be combined with the unique features of otherembodiments.

As perhaps best shown in FIGS. 9-11, forehead support bracket 154 ispivotally attached to an upper end portion 170 of forehead support arm156 so that the forehead support bracket rotates or rocks, as indicatedby arrow H in FIG. 9, about an axis defined on or near the foreheadsupport bracket. In this embodiment, the rocking movement of foreheadsupport bracket 154 relative to forehead support arm 156 is not locked,so that the forehead support bracket seeks the optimum position withoutuser intervention when the forehead support assembly is placed on thepatient.

To provide the pivotal attachment in this exemplary embodiment, upperend portion 170 of forehead support arm 156 includes a pair of walls 172that extend from the support arm. These walls are preferably slightlyflexible and include a protrusion 174 that provides a pivot axis (notshown). The pivot axis is disposed in a receiving slot defined inforehead support bracket 154. Unlike the embodiment shown in FIGS. 1-4,the flexibility of the walls allows the forehead support bracket to bedetached from the forehead support arm. This is particularly useful incleaning the patient interface device, removing the mask while theheadgear remains attached to the patient so that he or she does not haveto readjust the headgear each time the mask shell is removed, andallowing for different sized or shaped components to be used inconjunction with one another.

Chin support bracket 162 includes a chin support frame 180 and a chinsupport cushion 182 that selectively attaches to the chin support frame.Chin support frame 180 in this exemplary embodiment, is attached to chinsupport arm 164 is a slide-and-rotate arrangement that is similar tothat discussed above with respect to the attachment of the chin supportbracket to the chin support arm in FIGS. 1-4. Briefly stated, chinsupport frame 180 includes a pair of grooves 184 that are adapted toreceive a pair of protruding pivots 186 disposed on a lower end portionof chin support arm 164. A plurality of notches 188 are provided ingrooves 184 to receive the protruding pivots 186 so that the pivots canbe rotatably located at various locations along the length of grooves180. Thus, the sliding function is provided by allowing the protrudingpivots to move along the length of the grooves, and the rotatingfunction is provided by allowing the protruding pivots to rest in thenotches.

Chin support cushion 182 is preferably coupled to chin support frame 180in a removable fashion. To accomplish this, the chin support cushion andframe include engaging portions that can be selectively joined to oneanother. One such engaging portion is provided at the center of the chinsupport frame, and this arrangement is perhaps best shown in FIGS. 16and 17, and described in greater detail below. Another such engagingportion is provided by support arms 190 that extend from a bottomportion of chin support frame 180. Arms 190 also provide structuralsupport for the relatively flexible chin support cushion. Chin supportcushion 182 includes a pair of protrusions 192 that engage slots 196(see FIG. 17) provided in a distal end portion 194 of arms 190. Theflexible nature of protrusions 192 allows them to be readily insertedinto and removed from the slots in end portion 194 of arms 190.

A fifth exemplary embodiment for a patient interface device 200 isillustrated in FIGS. 13-17. Like in the previous embodiments, thisembodiment includes a forehead support assembly 201 having a foreheadsupport bracket 205 and a forehead support arm 203 and a chin supportassembly 202 having chin support bracket 180 and a chin support arm 204.In this illustrated embodiment, the forehead and chin support assembliesare connected to a mask shell 206 that includes a chamber for receivinga portion of user's face, such as the nose, and an opening to which thepatient circuit is attached. A patient contacting cushion (not shown) isattached to an end portion 208 of mask shell 206 in a fixed or removablefashion.

One unique feature of this embodiment is the manner in which theforehead support assembly 201 is attached to mask shell 206. In theprevious embodiments, the forehead support arm included an arcuateattaching member that extended from the mask shell to provide theforehead adjustment assembly. In this embodiment the arcuate attachingmember is, in effect, replaced by a forehead support adjustment track210 that is more flush with the mask shell as part of a foreheadadjustment assembly 207. Forehead support arm 203 attaches to foreheadsupport adjustment track 210 such that the forehead support arm movesalong the track and is selectively lockable into positions along thetrack via the teeth provided in the track. This arrangement forattaching the forehead support assembly to the mask shell and detailsregarding forehead support arm 203 and forehead support bracket 205 andtheir respective attachments to one another are described in U.S. patentapplication Ser. No. 10/654,379 (publication no. US-2004-0045551-A1),the contents of which are incorporated herein by reference.

A second unique feature for the patient interface device of thisembodiment is the manner in which chin support assembly 202 is attachedto mask shell 206. As in the previous embodiments, chin support assembly202 includes a chin adjustment assembly 212 that is defined by portionsof chin support arm 204. However, instead of having an arcuate attachingmember that extends from the bottom portion of the mask, chin adjustmentassembly 212 and chin support arm 204 include a first attaching member214. In addition, an arcuate support member 213 is slidably coupled toan end portion of first attaching member 214, so that chin supportbracket 180 is adjustably connectable to mask shell 206.

First attaching member 214 has an end portion 216 that attaches to themask shell by surrounding an opening 218 to which a patient circuit (notshown) is attached. More specifically, end portion 216 includes andopening 220 through which the patient circuit is inserted. When thepatient circuit is inserted through opening 220 and engaged in opening218 of mask shell 206, end portion 216 of first attachment member 214 iseffectively attached to the mask shell. An advantage of thisconfiguration is that it allows the chin support assembly to be retrofitonto existing masks. It also allows the chin support assembly to beattached to any mask in a removable fashion, whether or not retrofitted,so that a mask user can select a mask for use, and decide whether to addthe chin support assembly as an optional accessory for the mask.

As shown in FIGS. 16 and 17, chin support cushion 182 includes at leastone attachment member 230 that is preferably formed from the sameflexible material as the rest of the chin support cushion. Attachmentmembers 230 are configured, sized, and arranged so that they insert intocorresponding slots defined in chin support fame 180 and are retainedthere.

A sixth exemplary embodiment for a patient interface device 250 isillustrated in FIG. 18. Patient interface device 250 is similar topatient interface device 200 in that it includes the same chin supportassembly 202 that selectively attaches to the patient circuit thatattaches to the mask shell. The primary difference between thisembodiment and that shown in FIGS. 13-17 resides in the configurationfor forehead support assembly 252 that is coupled to mask shell 254.More specifically, forehead support assembly 252 includes a foreheadsupport bracket 258 and a forehead support arm 260. In this embodiment,unlike the previous embodiments, the forehead support bracket ismaintained in a fixed position relative to mask shell 254. This isaccomplished in this embodiment by defining forehead support bracket258, forehead support arm 260, and mask shell 254 in one integratedpiece. This embodiment clarifies that the present invention contemplatesthat the forehead support assembly, as well as the chin supportassembly, need not provide adjustment of the forehead support bracket orthe chin support bracket relative to the mask shell.

Mask shell 254 and forehead support assembly 252 shown in FIG. 18corresponds to the patient interface device described in U.S. Pat. No.6,467,483, the contents of which are incorporated herein by reference.It is to be understood, however, that the present invention contemplatesother configurations for the forehead support assembly and maskcomponents.

The patient interface device communicates a flow of breathing gasbetween the patient's airway and pressure generating device, such as aventilator, CPAP device, or variable pressure device, e.g., anauto-titrating pressure support device or a BiPAP® device manufacturedand distributed by Respironics, Inc. of Pittsburgh, Pa., in which thepressure provided to the patient varies with the patient's respiratorycycle so that a higher pressure is delivered during inspiration thanduring expiration or an auto-titratition pressure support system wherethe pressure varies with the condition of the patient, such as whetherthe patient is snoring or experiencing an apnea or hypopnea.

Communicating a flow of breathing gas between the patient's airway and apressure generating device includes delivering a flow of breathing gasto the patient from the pressure generating device and exhausting a flowof gas from the patient to ambient atmosphere in the case of single-limbcircuit. The system for delivering a breathing gas to a patientaccording to the present invention comprises a pressure or gas flowgenerating device 12 that produces a flow of gas, a conduit 26 having afirst end portion operatively coupled to the gas flow generating device12 and a second end portion, wherein the conduit 26 carries the flow ofgas from the gas flow generating device 12 during operation of thesystem; a gas delivery mask assembly 10 coupled to the second endportion of the conduit; and a headgear. It is to be understood thatother accessories used in a pressure support system, such as ahumidifier, pressure sensor, flow sensor, temperature sensor, humiditysensor, bacteria filter, etc. can be used in conjunction with thepatient interface device of the present invention.

In the illustrated embodiment, the adjustment assemblies FIGS. 1-6 and8-18 are configured to allow for curvilinear movement of the foreheadand chin supports relative to the mask shell. It is to be understood,however, that the present invention contemplates that the adjustmentassemblies can provided other patterns of translational movement of theforehead and chin supports relative to the mask shell. For example, theattaching member can have an “S” shaped pattern, or a “J” shaped patternso that the support is moveable in an “S” or “J” pattern relative to themask shell.

In the above-described embodiments for the patient interface device ofthe present invention, the pads that attach to the forehead supportassemblies and the chin support assemblies and that contact the surfaceof the patient were discussed briefly. It is to be understood that thepresent invention contemplates attaching any conventional pad to thepresent forehead support assemblies and the chin support assemblies. Forexample, various types of patient contacting pads suitable for use withthe present invention is described in U.S. patent application Ser. No.10/884,060 (publication no. US-2005-0011522-A1), the contents of whichare incorporated herein by reference. Those skilled in the art willunderstand, however, that other pads, and materials for the pad (such asgels, foams, silicon, and fabric) can be used in conjunction with thepatient interface device of the present invention.

It can also be appreciated that the description of the presentinvention, while discussing some different embodiments for the seal andmask, is not intended to be an exhaustive listing of the seals and maskssuitable for use with the patient interface device of the presentinvention. On the contrary, those skilled in the art can appreciate thatthe mask shell can have almost any configuration or size and still beused in conjunction with the patient interface device of the presentinvention. Moreover, the mask shell and cushion can be combined into asingle structure to which the forehead and chin support assemblies aremounted and still remain within the teachings of the present invention.

Although the invention has been described in detail for the purpose ofillustration based on what is currently considered to be the mostpractical and preferred embodiments, it is to be understood that suchdetail is solely for that purpose and that the invention is not limitedto the disclosed embodiments, but, on the contrary, is intended to covermodifications and equivalent arrangements that are within the spirit andscope of the appended claims.

1. A patient interface comprising: a mask shell having a longitudinalaxis; a sealing member coupled to the mask shell; a forehead supportassembly associated with the mask shell, wherein the forehead supportassembly includes a forehead pad, and wherein the forehead supportassembly is adjustable relative to the mask shell generally along thelongitudinal axis so that a position of the forehead pad relative to themask shell can be adjusted; and a chin support assembly associated withthe mask shell, wherein the chin support assembly includes a chin pad,and wherein the chin support assembly is adjustable relative to the maskshell generally along the longitudinal axis so that a position of thechin pad relative to the mask shell can be adjusted to control adistance between the chin pad and the mask shell.
 2. The patientinterface of claim 1, wherein the forehead support assembly comprises:an attaching member coupled to the mask shell; and a support membermoveably coupled to the attaching member.
 3. The patient interface ofclaim 2, wherein the attaching member and the support member havecomplimentary shapes such that at least a portion of one of theattaching member and the support member is slidable within at least aportion of a remaining other of the attaching member and the supportmember generally along the longitudinal axis.
 4. The patient interfaceof claim 3, wherein the attaching member comprises a track memberoperatively coupled to the mask shell and the support member includes aportion adapted to engage the track member.
 5. The patient interface ofclaim 1, wherein the forehead support assembly comprises: a foreheadsupport arm operatively coupled to the mask shell; and a foreheadsupport bracket operatively coupled to the forehead support arm, whereinthe forehead pad is operatively coupled to the forehead support bracket.6. The patient interface of claim 5, wherein the forehead supportbracket is movably coupled to the forehead support arm.
 7. The patientinterface of claim 5, wherein the forehead support arm is a flexiblemember.
 8. The patient interface of claim 7, wherein a position of theforehead support bracket along a length of the flexible member isadjustable.
 9. The patient interface of claim 5, wherein the foreheadsupport bracket is maintained in a fixed position relative to the maskshell via the forehead support arm.
 10. The patient interface of claim1, wherein the forehead support assembly, the chin support assembly, orboth the forehead support assembly and the chin support assembly areselectively attachable to the mask shell.
 11. The patient interface ofclaim 1, wherein the chin support assembly comprises: an attachingmember operatively coupled the mask shell; and a support member moveablycoupled to the attaching member.
 12. The patient interface of claim 11,wherein the attaching member and the support member have complimentaryshapes such that at least a portion of one of the attaching member andthe support member is slidable within at least a portion of a remainingother of the attaching member and the support member generally along thelongitudinal axis.
 13. The patient interface of claim 11, wherein theattaching member comprises a track member operatively coupled to themask shell and the support member includes a portion adapted to engagethe track member.
 14. The patient interface of claim 1, wherein the chinsupport assembly comprises: a chin support arm operatively coupled tothe mask shell; and a chin support bracket operatively coupled the chinsupport arm, wherein the chin pad is operatively coupled to the chinsupport bracket.
 15. The patient interface of claim 14, wherein the chinsupport bracket is movably mounted on the chin support arm.
 16. Thepatient interface of claim 14, wherein the chin support arm is aflexible member.
 17. The patient interface of claim 16, wherein aposition of the chin support bracket along a length of the flexiblemember is adjustable.
 18. The patient interface of claim 14, wherein thechin support bracket is maintained in a fixed position relative to andthe mask shell via the chin support arm.
 19. The patient interface ofclaim 1, wherein the forehead support assembly comprises: a foreheadsupport arm operatively coupled to the mask shell; and a foreheadsupport bracket mounted on the forehead support arm, and wherein thechin support assembly comprises: a chin support arm operatively coupledto the mask shell; and a chin support bracket mounted on the chinsupport arm.
 20. The patient interface of claim 19, wherein the foreheadsupport bracket is movably mounted on the forehead support arm, andwherein the chin support bracket is movably mounted on the chin supportarm.